BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 19512160 · Received June 11, 2024

    Report

    Report Number
    3004209178-2024-12605
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    June 4, 2024
    Report Date
    June 11, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD A RETURN OF PAIN. IT WAS REPORTED THAT THE PATIENT HAD THE FOLLOWING HIGH IMPEDANCE READINGS: 5: DO NOT USE 40000, 8: AVOID 19400, 9: DO NOT USE 40000, 10: DO NOT USE 40000, 13: AVOID 37600, 14: AVOID 30100, AND 15: DO NOT USE 40000. REPROGRAMMING AROUND AVOID AND DO NOT USE ELECTRODES WERE DONE AND THE PATIENT WAS ABLE TO GET COVERAGE, BUT RESTRICTED THEIR PROGRAMMING OPTIONS. THE CAUSE WAS REPORTED TO BE RELATED TO THE PATIENT HAVING REGULAR FALLS. IT  WAS UNKNOWN FI THE ISSUE WAS RESOLVED. THE MANUFACTURER REPRESENTATIVE INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089773 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female